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Leukaemia for shared care centres Workshop session

Attend the workshop session by Caroline Osborne and Julia Hitchin from Alder Hey, at the NPPG conference on 11th November 2012. Learn about the UKALL 2011 clinical trial and its implications for your POSCU. Understand your responsibilities in dispensing for this trial.

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Leukaemia for shared care centres Workshop session

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  1. Leukaemia for shared care centresWorkshop session Caroline Osborne & Julia Hitchin (Alder Hey) NPPG conference 11th November 2012

  2. Workshop content • Presentation • Children’s Cancer Measures • Shared care levels for POSCUs • Clinical Trial Issues • Background – other trial results (UK and international) • Objectives of UKALL 2011 • UKALL 2011 trial summary • IMPs/NIMPs • Pharmacy responsibilities • UKALL 2011 Prescription verification exercise • Open discussion

  3. Aims of session • Have an understanding of the UKALL 2011 clinical trial • Understand the implications of this trial for your POSCU • Be aware of your responsibilities in dispensing for this clinical trial

  4. Children’s Cancer Measures 2005 NICE Improving Outcomes Guidance in Children and Young People with Cancer 2009 Manual for Cancer Services , Children’s Cancer Measures. Part of National Cancer Peer Review Programme. 2011 - V2.1 Birth to 16 years

  5. Children’s Cancer Measures Principle Treatment Centre (PTC) – 20, linked to CCLG Paediatric Oncology Shared Care Unit (POSCUs) Self assessment, Internal Validation, external review

  6. Shared care levels for POSCUs • Level 1 • Supportive care • Out patient Oral chemo • Out patient IV bolus • Level 2 • As level 1 PLUS • Day case infusional chemo • Level 3 • As level 2 plus inpatient 24 hour chemotherapy Everything except diagnosis, trial enrolment, BMT etc

  7. Clinical Trial Issues • IMP = Investigational Medicinal Product • a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form • NIMP = Non-Investigational Medicinal Product (i.e. any other drug used within protocol)

  8. IMP management • IMPs may be licensed medication that only becomes IMP once taken off shelf to dispense OR • Trial specific products that must be ordered, stored and recorded specifically for the trial • Drug accountability is required for all IMPs • Labelling – need to attach a trial specific label (supplied by trial sponsor) to each container of IMP dispensed as well as dispensing label

  9. Background • Results of UKALL 2003 show an improvement in EFS of 6% (87%) • Among the best reported to date internationally • Various recent international trials (COG and BFM) have been reviewed whilst making the changes to UKALL 2011 • UKALL 2011 aims to further improve survival and quality of survival by addressing 4 main issues apparent from UKALL 2003

  10. UKALL 20034 main areas of concern • Treatment related morbidity and mortality too high in context of DFS 87% • 100 non-relapse deaths in CR, 25% all patients have at least 1 SAE • Marked reduction in QoL • TRM commonest during induction and delayed intensive (Dexamethasone) • Very poor prognosis of early marrow relapse • <20% survive even after transplant

  11. UKALL 20034 main areas of concern • Concerns over efficacy and burden of therapy of CNS prophylaxis (i.e. IT’s) • Superior outcome for young adults treated on paediatric protocol • Up to age 24. Previously treatment depended on place of presentation/choice • Needs more uniform approach so all young adults get treated the same

  12. Aims & Objectives of UKALL 2011 • Reduce toxicity through introduction of short 14-day course high dose dexamethasone instead of conventional 28 day lower dose (randomised) • More effective CNS prophylaxis and reduce burden of therapy by introducing high dose IV methotrexate and by omission of vincristine and dex pulses (randomised) • Decrease toxicity and reduce burden of therapy by administering a single delayed intensification to all patients (non-randomised)

  13. UKALL 2011Inclusion • Age 1 year to < 25 years • First diagnosis of acute lymphoblastic leukaemia or: • Lymphoblastic lymphoma (T-NHL or precursor negative B-NHL)

  14. Regimen A (Standard risk) Induction • B cell precursor ALL < 10 years of age and highest WCC <50 • All Downs syndrome patients • Randomised to standard dexamethasone (IMP) 6mg/m2/day in 2 doses (capped at 10mg/day) for 28 days then taper over next 7 days • OR short dexamethasone (IMP) 10mg/m2/day in 2 doses (not capped & no taper) for 14 days • Weekly vincristine • PEG Asparaginase • Intrathecal Methotrexate

  15. Regimen B (High risk) Induction • B cell precursor ALL > 10 years of age and/or highest WCC >50 • All T cell ALL and T cell lymphoblastic lymphoma • Randomised to standard dexamethasone (IMP) 6mg/m2/day in 2 doses (capped at 10mg/day) for 28 days then taper over next 7 days • OR short dexamethasone (IMP) 10mg/m2/day in 2 doses (not capped & no taper) for 14 days • (NB >10 years “short dex” get 2 x 7 day blocks weeks 1 & 3 – reduced risk osteonecrosis) • Weekly daunorubicin and vincristine • PEG Asparaginase • Intrathecal Methotrexate

  16. Day 29 MRD • Low risk – continue regimen A or B as allocated for induction • Risk – augmented BFM consolidation regimen C • No result – determine post induction therapy based on early response

  17. Post induction treatment – Regimen A

  18. Post induction treatment – reg B

  19. Interim maintenance (standard arm) • As in UKALL 2003 (ALL IMPS) • Dexamethasone 5 day pulse each month • Vincristine monthly • Continuous oral mercaptopurine 75mg/m2/day for 8 weeks • Oral methotrexate weekly omitting in weeks when get intrathecals • Intrathecal methotrexate monthly

  20. Protocol M – High Dose methotrexate (experimental arm) • ALL IMPs • Oral mercaptopurine 25mg/m2/day for 8 weeks (NB much lower dose than elsewhere) • IV Methotrexate 5g/m2 every 14 days for 4 doses • Intrathecal methotrexate – within 2 hours of start of IV Methotrexate

  21. Delayed Intensive (reg A week 18 – 24) (reg B week week 20-26) All NIMPs • As per UKALL 2003 except no Intrathecals in part 2 • Part 1 - Vinc, Dox, PEG, IT day 1, Dex 10mg/m2/day for 7 days week 1 & 3 • Part 2 - Cyclo, Cytarabine, oral Mercaptopurine 60mg/m2/day for 14 days

  22. Maintenance • All patients get • Oral Mercaptopurine (NIMP) 75mg/m2/day continuous (adjusted for counts) • Oral Methotrexate (NIMP) 20mg/m2 once a week (omitted week of IT & adjusted for counts) • Pulses (randomised to receive or not) • Dexamethasone (IMP) 6mg/m2/day for 5 days every 4 weeks • Vincristine (IMP) 1.5mg/m2 every 4 weeks • Intrathecals (IMP) (NOT for patients who got protocol M) • IT Methotrexate day 15 of each 12 week cycle • NB Septrin continues throughout

  23. Regimen C • Induction • Only for reg A subsequently found to have high risk cytogenetics OR Downs syndrome with SER • Continue Dex as randomised • Continue Vinc • Daunorubicin day 16 & 23 (higher dose than reg B)

  24. Post induction treatment – reg C

  25. Capizzi interim maintenance (standard arm) (all IMPs) • As UKALL 2003 • Vincristine every 10 days with escalating IV Methotrexate doses • PEG Asparaginase • Intrathecal methotrexate

  26. Protocol M-A (experimental arm) (all IMPs) • As reg A/B with addition of Peg Asp

  27. Delayed Intensive – reg C (weeks 24-31) All NIMPs • As per UKALL 2003 • As regimen A/B

  28. Special IMPs • Mercaptopurine 10mg tabs and PEG Asparaginase, licensed in Germany, must use Medice (Medac UK) for both • Methotrexate liquid for IMP is trial specific from Stockport • In NIMP phase use special from Stockport • Mercaptopurine suspension – is now a licensed product (NOVA) but initially this is trial specific IMP from NOVA • When NIMP must use licensed NOVA product

  29. Pharmacy Responsibilities • Maintaining pharmacy file and signing relevant delegation logs • IMP ordering, ensuring only approved preparations are used • IMP storage in controlled temperature environment • Drug accountability of all IMPs • Ensure prescription is identified as clinical trial and IMPs are highlighted • Identification of IMP by approved trial label in addition to dispensing label • Recording returns and safely disposing of them

  30. Useful Links • NPPG and POP group • Your local cancer network –see the Department of Health website for a full list www.dh.gov.uk • www.bopawebsite.org – learning centre: Verification of Chemotherapy Prescriptions in Paediatrics Module • www.macmillan.org.uk – aimed at public but lots of useful information • www.cclg.org.uk • www.cquins.nhs.uk – children's cancer measures

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